Open AccessLong‐Term Efficacy and Safety of Triple‐Combination Therapy With Olmesartan Medoxomil and Amlodipine Besylate and Hydrochlorothiazide for Hypertension
Author(s) -
Kereiakes Dean J.,
Chrysant Steven G.,
Izzo Joseph L.,
Littlejohn Thomas,
Oparil Suzanne,
Melino Michael,
Lee James,
Fernandez Victor,
Heyrman Reinilde
Publication year - 2012
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/j.1751-7176.2011.00588.x
Subject(s) - hydrochlorothiazide , olmesartan , medicine , amlodipine , urology , blood pressure , combination therapy , randomization , pharmacology , randomized controlled trial
J Clin Hypertens (Greenwich) . 2012;14:149–157. ©2012 Wiley Periodicals, Inc. Most patients with hypertension require combination therapy in order to achieve blood pressure (BP) goals. This 40‐week open‐label extension of the 12‐week double‐blind Tri ple Therapy With Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hyperte n s i ve Patien t s Stud y (TRINITY) evaluated the efficacy and safety of triple‐combination treatments with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide (OM/AML/HCTZ) in 2112 participants with moderate to severe hypertension. Following 2 weeks of initial treatment with OM 40/AML 5/HCTZ 12.5 mg, participants not achieving BP goal were titrated to OM 40/AML 5/HCTZ 25 mg or OM 40/AML 10/HCTZ 12.5 mg on a randomized basis. At week 16, participants who did not achieve BP goal were further titrated to OM 40/AML 10/HCTZ 25 mg. At the end of the study, 44.5% to 79.8% of participants reached BP goal and the mean BP decreased from 168.6/100.7 mm Hg (baseline BP at randomization) to 125.0 to 136.8 mm Hg/77.8 to 82.5 mm Hg, depending on treatment. Long‐term treatment with OM/AML/HCTZ was well tolerated and effective with no new safety concerns.